Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.
Between 3 and 19% of patients with clinical and polysomnographic features of obstructive sleep apnea syndrome (OSA) develop a high-frequency of central apneas and/or disruptive Cheyne-Stokes respiratory syndrome after application of continuous positive airway pressure (CPAP), a pattern called the complex sleep apnea syndrome (CompSAS). The trial seeks to determine the efficacy of the ASV vs. CPAP modes for the treatment of CompSAS over time. Baseline clinical and laboratory data will be collected, patients will be randomized to one of the two treatments. Overall study participation is approximately 3 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASV mode | Active Comparator |
| |
| CPAP mode | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPAP Adapt SV | Device | Comparison of ASV and CPAP modes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period | AHI refers to the number of apneas and hypopneas that occurred per hour of sleep | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) | Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy I Morgenthaler, MD | Mayo Sleep Disorders Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| REM Medical | Phoenix | Arizona | 85037 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24790271 | Derived | Morgenthaler TI, Kuzniar TJ, Wolfe LF, Willes L, McLain WC 3rd, Goldberg R. The complex sleep apnea resolution study: a prospective randomized controlled trial of continuous positive airway pressure versus adaptive servoventilation therapy. Sleep. 2014 May 1;37(5):927-34. doi: 10.5665/sleep.3662. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ASV Mode | VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea |
| FG001 | CPAP Mode | VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ASV Mode | VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea |
| BG001 | CPAP Mode | VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period | AHI refers to the number of apneas and hypopneas that occurred per hour of sleep | Posted | Mean | Standard Deviation | AHI (events/hour) | 3 months |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ASV Mode | VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial irritation/rash | Skin and subcutaneous tissue disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| June Mendoza | ResMed | 1-800-424-0737 | june.mendoza@resmed.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Chicago |
| Illinois |
| 60611 |
| United States |
| NorthShore University Health System | Skokie | Illinois | 60077 | United States |
| Mayo Center for Sleep Medicine, Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Center for Sleep Medicine | Lafayette Hill | Pennsylvania | 19444 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) | Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| 0 |
| 33 |
| 8 |
| 33 |
| EG001 | CPAP Mode | VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea | 3 | 33 | 9 | 33 |
| Heart attack | Cardiac disorders |
|
| Rebound hypertension | Cardiac disorders |
|
| Skin breakdown (from mask) | Skin and subcutaneous tissue disorders |
|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders |
|
| Other sinus issues | Respiratory, thoracic and mediastinal disorders |
|
Not provided